Renamel® Microhybrid 6061B2

GUDID EDEL6061B20

Renamel® Microhybrid Body B2, Syringe 5g

DeltaMed GmbH

Dental composite resin

• Primary Device ID: EDEL6061B20
• NIH Device Record Key: 7a175592-ddf1-48c8-9bf4-3e7f84690641
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Renamel® Microhybrid
• Version Model Number: 6061B2
• Catalog Number: 6061B2
• Company DUNS: 344805101
• Company Name: DeltaMed GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D7796061B20 [Previous]
HIBCC	EDEL6061B20 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222435

FDA Product Code

• EBF: Material, Tooth Shade, Resin

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-08
• Device Publish Date: 2023-05-31

On-Brand Devices [Renamel® Microhybrid]

• EDEL616MWO0: Renamel® Microhybrid Milky White Occlusal, Syringe 2g
• EDEL616A350: Renamel® Microhybrid Body A3.5, Syringe 2g
• EDEL6161MI0: Renamel® Microhybrid Medium Incisal, Syringe 2g
• EDEL6161D30: Renamel® Microhybrid Body D3, Syringe 2g
• EDEL6161D20: Renamel® Microhybrid Body D2, Syringe 2g
• EDEL6161CO0: Renamel® Microhybrid Clear Occlusal, Syringe 2g
• EDEL6161C40: Renamel® Microhybrid Body C4, Syringe 2g
• EDEL6161C30: Renamel® Microhybrid Body C3, Syringe 2g
• EDEL6161C20: Renamel® Microhybrid Body C2, Syringe 2g
• EDEL6161C10: Renamel® Microhybrid Body C1, Syringe 2g
• EDEL6161B30: Renamel® Microhybrid Body B3, Syringe 2g
• EDEL6161B20: Renamel® Microhybrid Body B2, Syringe 2g
• EDEL6161B10: Renamel® Microhybrid Body B1, Syringe 2g
• EDEL6161B00: Renamel® Microhybrid Body B-Zero, Syringe 2g
• EDEL6161A40: Renamel® Microhybrid Body A4, Syringe 2g
• EDEL6161A30: Renamel® Microhybrid Body A3, Syringe 2g
• EDEL6161A20: Renamel® Microhybrid Body A2, Syringe 2g
• EDEL6161A10: Renamel® Microhybrid Body A1, Syringe 2g
• EDEL613SB30: Renamel® Microhybrid SuperBrite 3, Syringe 5g
• EDEL613SB20: Renamel® Microhybrid SuperBrite 2, Syringe 5g
• EDEL613SB10: Renamel® Microhybrid SuperBrite 1, Syringe 5g
• EDEL606MWO0: Renamel® Microhybrid Milky White Occlusal, Syringe 5g
• EDEL606A350: Renamel® Microhybrid Body A3.5; Syringe 5g
• EDEL6062MW0: Renamel® Microhybrid Milky White Occlusal, 10 Compules
• EDEL6062MI0: Renamel® Microhybrid Medium Incisal, 10 Compules
• EDEL6062LI0: Renamel® Microhybrid Light Incisal, 10 Compules
• EDEL6062D40: Renamel® Microhybrid Body D4, 10 Compules
• EDEL6062D30: Renamel® Microhybrid Body D3, 10 Compules
• EDEL6062D20: Renamel® Microhybrid Body D2, 10 Compules
• EDEL6062CO0: Renamel® Microhybrid Clear Occlusal, 10 Compules
• EDEL6062C40: Renamel® Microhybrid Body C4, 10 Compules
• EDEL6062C30: Renamel® Microhybrid Body C3, 10 Compules
• EDEL6062C20: Renamel® Microhybrid Body C2, 10 Compules
• EDEL6062C10: Renamel® Microhybrid Body C1, 10 Compules
• EDEL6062B40: Renamel® Microhybrid Body B4, 10 Compules
• EDEL6062B30: Renamel® Microhybrid Body B3, 10 Compules
• EDEL6062B20: Renamel® Microhybrid Body B2, 10 Compules
• EDEL6062B10: Renamel® Microhybrid Body B1, 10 Compules
• EDEL6062B00: Renamel® Microhybrid Body B-Zero, 10 Compules
• EDEL6062A40: Renamel® Microhybrid Body A4, 10 Compules
• EDEL6062A30: Renamel® Microhybrid Body A3, 10 Compules
• EDEL6062A20: Renamel® Microhybrid Body A2, 10 Compules
• EDEL6062A10: Renamel® Microhybrid Body A1, 10 Compules
• EDEL6062350: Renamel® Microhybrid Body A3.5, 10 Compules
• EDEL60620W0: Renamel® Microhybrid Body White, 10 Compules
• EDEL6061MI0: Renamel® Microhybrid Medium Incisal, Syringe 5g
• EDEL6061LI0: Renamel® Microhybrid Light Incisal, Syringe 5g
• EDEL6061D40: Renamel® Microhybrid Body D4, Syringe 5g
• EDEL6061D30: Renamel® Microhybrid Body D3, Syringe 5g
• EDEL6061D20: Renamel® Microhybrid Body D2, Syringe 5g